Laterza Francesco
Global Quality & Regulatory Manager - Medical Devices @SGS
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WORK HISTORY
Global Quality & Regulatory Manager - Medical Devices @SGS
Turin, IT
EDUCATION
ITIS Giovanni Giorgi, Brindisi
Diploma with full grade (60/60), Informatics sciences
Collegio Universitario di Torino Renato Einaudi
University College, Engineering
Politecnico di Torino
Post-graduate Fellowship, Biomedical Research lab
Politecnico di Torino
Laurea, Electronics/Biomedical engineering
SKILLS
ABOUT LATERZA FRANCESCO
Enthusiastic team leader with extensive experience in Regulatory Affiars in EU, APAC, and a sounds of exparience in USA, in global medical device organizations.20+ years regulatory and related quality assurance experience in companies’ leaders in the medical device business. Strategic directions and oversight of strategic projects including MDR remediations, spin-offs, marging, re-organization, site relocation and company legal entity restructuring, dealing with with the most relevant NB’s. Good sounds of experience with FDA 510K and PMA submissions and ROW product registrations in the most relevant internationals markets like China, India, Australia, Brazil, Colombia and Mexico. Qualified as MDD/MDR and ISO13485 final reviewer and certification decision maker in a prominent Notified Body (NB0086 and NB2797), representing the company in international conferences.Reviewed and released more than 350 ISO13485 and 30 CE certs. Released the first MDR certificate in EU. Participations as lecturer in Executive Master classrooms with a good sound of scientific publications Primary contact point for Int’l competent authorities. PRRC qualified.Gallup Strengths: Arranger, Significance, Learner, Focus, Individualization, Achiever, Activator, Futuristic, Strategic, Self-Assurance
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